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The US Food and Drug Administration issued a public health advisory warning of fatal adverse events in demented patients treated with atypical antipsychotic drugs. Seventeen controlled studies of elderly demented patients have shown that patients treated with the drugs were 1.6 to 1.7 times more likely to die than patients given placebo. The causes of death included congestive heartfailure, sudden death, and infections, such as pneumonia.

The FDA asked manufacturers to place a “black box” warning on drug labels—indicating an adverse reaction that may result in death or serious injury—noting the increased death rates and that “these drugs are not approved for the treatment of behavioural symptoms in elderly patients with dementia.”